# K222822: VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

- Pathway: 510(k) (Traditional)
- Applicant: Draegerwerk AG & CO Kgaa
- Decided: Jun 14, 2023 after 268 days
- Product code: BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer)
- Device class: 2
- Regulation: 21 CFR 868.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913368 (1992). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103767: Dual Heated Infant Vreathing Cirouits, Fisher & Paykel Healthcare, Ltd. (2012) Summary page 4.
- K102618: Ventstar Heated, Infinity ID Breathing Circuit Heated, Draeger Medical AG & Co. KG (2010) Summary page 4.

## Most influential descendants
- K242769: VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (2025), 0 descendants of its own

## Indications for use
VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory and expiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient. VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.

Source page: https://510kreport.com/device/K222822
Methodology: https://510kreport.com/methodology